Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer

NCT05356585 | Withdrawn

• 1 other identifier: CASE9221
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short.

Conditions

Colorectal Cancer; Rectal Cancer

Keywords

total neoadjuvant treatment; tumor-specific assay; Circulating Tumor DNA; ctDNA

Outcome Measures

Primary Outcomes (1)

• Detectable ctDNA at the Completion of TNT

  The percentage of participants with detectable ctDNA at the completion of TNT

  up to 24 months after TNT

Secondary Outcomes (2)

• Change in ctDNA

  up to 24 months after TNT

• Correlation of Complete Response TNT

  Up to 24 months after TNT

Other Outcomes (2)

• The recurrence rate (local and distant) with positive ctDNA and negative ctDNA after TNT

  Up to 24 months after TNT

• The correlation of ctDNA at end of TNT with relapse-free survival

  After 2 years of surveillance post-TNT

Interventions

SignateraTM assay GENETIC

A customized tumor-informed ctDNA test that, after receiving the tumor tissue, examines whole exome sequencing of a biopsied tumor to find the somatic tumor-derived mutations. From those mutations, the 16 most clonal mutations are used to create a personal assay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will consist of individuals of any gender who are 18 years of age or older. They will all have a diagnosis of stage II or III rectal adenocarcinoma or adenoma.

You may qualify if:

• Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma with MRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or III disease
• Plan is for participant to undergo standard TNT with induction chemoradiation
• Age ≥ 18 years of age

You may not qualify if:

• Stage I, recurrent, or metastatic rectal cancer
• Received prior therapy for this rectal cancer
• No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue from biopsies available to send for SignateraTM assay development

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed, paraffin embedded tissue from the patient's colonoscopy or flexible sigmoidoscopy in surgeon's office will be sent to Natera for Signatera assay creation after enrollment onto the study Blood will be collected in Ethylenediamine tetraacetic acid (EDTA) tubes and sent to Natera via shipping materials provided by Natera.

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Smitha Krishnamurthi, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: December 30, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

US (1)